Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals

NCT03711318 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 7699
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

A short-term treatment with buprenorphine prior to initiating treatment with naltrexone may increase the proportion of heroin-dependent patients successfully inducted onto Vivitrol.

Conditions

Heroin Dependence

Outcome Measures

Primary Outcomes (1)

• Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol

  Number of patients who received the first Vivitrol injection among those who initiated the induction

  12 weeks

Study Arms (1)

Short-term treatment with buprenorphine

EXPERIMENTAL

Short-term treatment with buprenorphine

Drug: Buprenorphine/naloxone

Interventions

Buprenorphine/naloxone DRUG

3 week treatment with buprenorphine/naloxone

Short-term treatment with buprenorphine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals between the ages of 18-60
• Meets DSM-5 criteria of current opioid use disorder with six consecutive months of reported heroin use, supported by a positive urine for opiates indicating regular use of heroin
• Seeking treatment for opioid use disorder with Vivitrol
• Capable of giving informed consent and complying with study procedures
• In otherwise good health based on complete medical history and physical examination, laboratory tests, and EKG
• BMI between 18-40

You may not qualify if:

• Reported treatment with methadone in the last 3 months or positive urine toxicology for methadone on the day of consent
• Maintenance on, or regular use of buprenorphine or other prescription opioids
• Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
• Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with AST or ALT \> 3 times normal, AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection), unstable diabetes, cardiovascular disease.
• Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-5 Schizophrenia or any psychotic disorder, severe Major Depressive Disorder, or suicide risk or 1 or more suicide attempts within the past year.
• History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
• Chronic neurocognitive disorder
• History of accidental drug overdose in the last 3 years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
• Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications
• Fentanyl only use, supported by a urine toxicology that is positive for fentanyl only and negative for all other opioids.
• Court mandated to treatment

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Alkermes, Inc.: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Heroin Dependence

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Adam Bisaga, study PI
• Organization: NYS Psychiatric Institute

adam.bisaga@nyspi.columbia.edu

646-774-6155

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 18, 2018
• Study Start: November 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 22, 2022
• Results First Posted: December 22, 2022

Record last verified: 2022-11

Locations

US (1)